Abstract:

An energetic or nutritive composition includes at least one compound
having laxative properties, mineral salts (or electrolytes) such as
sodium, potassium, chlorine, calcium, magnesium, phosphor. The
composition may also include carbohydrates that may be assimilated by the
human digestive system such as glucose, galactose, fructose, maltose,
saccharose, polysaccharides.

2. The energetic or nutritive composition according to claim 1 having an
energy value larger than or equal to 250 kcal.

3. The energetic or nutritive composition according to claim 1 having an
energy value larger than or equal to 500 kcal.

4. The energetic or nutritive composition according to claim 1 having an
energy value larger than or equal to 1000 kcal.

5. The energetic or nutritive composition according to claim 1 wherein the
compound having laxative properties belongs to the class of osmotic
laxatives.

6. The energetic or nutritive composition according to claim 5 wherein the
compound having laxative properties is polyethylene glycol (PEG) the
average molecular weight of which is larger than or equal to 3000 kDa.

7. The energetic or nutritive composition according to claim 6 wherein the
compound having laxative properties is polyethylene glycol (PEG) for
which the average molecular weight is comprised between 3000 kDa and
20000 kDa.

8. The energetic or nutritive composition according to claim 5 wherein the
compound having laxative properties is polyethylene glycol (PEG) the
average molecular weight of which is 3350 kDa.

9. The energetic or nutritive composition according to claim 1 which
comprises trace elements.

10. The energetic or nutritive composition according to claim 1 which
comprises proteins.

11. The energetic or nutritive composition according to claim 1 which
comprises vitamins such as ascorbic acid.

12. A kit comprising:either at least one sachet or flask containing the
composition according to claim 1; orat least one sachet or flask
containing a laxative, at least one sachet or flask containing one or
more mineral salts and at least one sachet or flask containing
carbohydrates; forming a composition according to claim 1; orat least one
sachet or flask containing a laxative and at least one sachet or flask
containing one or more mineral salts and carbohydrates; forming a
composition according to claim 1.

Description:

FIELD OF THE INVENTION

[0001]The present invention relates to an energetic or nutritive
composition intended for preparing the digestive tract prior to a
physical check-up such as an endoscopic examination (flexible endoscopy
or endoscopic capsule), radiological or a therapeutic intervention.

STATE OF THE ART

[0002]Prior to an examination of the digestive tract, it is absolutely
necessary that the latter be cleaned of stools which obstruct it in order
to allow adequate viewing of the mucosa.

[0003]Several classifications of the quality of the preparation have been
established. (Eliakim et al. Evaluation of the PillCam Colon capsule in
the detection of colonic pathology: results of the first multicenter,
prospective, comparative study. Endoscopy 2006; 38(10):963-970,
[0004]Vanner et al. A randomized prospective trial comparing oral sodium
phosphate with standard polyethylene glycol-based lavage solution
(Golytely) in the preparation of patients for colonoscopy. American
Journal of Gastroenterology 1990; 85:422-427, [0005]Barclay et al.
Carbohydrate-electrolyte re-hydration protects against intravascular
volume contraction during colonic cleansing with orally administered
sodium phosphate. Gastrointestinal Endoscopy 2002; 56:633-8). According
to Eliakim et al., it is possible to classify the preparation in
different grades, from grade 1 (excellent preparation) to grade 4
(insufficient preparation compromising the quality of the examination).
Vanner et al. propose another classification described hereafter:
excellent preparation=small volume of clear liquid; good
preparation=important volume of clear liquid; acceptable
preparation=limited half-solid stools which can be sucked up or cleaned;
insufficient preparation=half-solid stools.

[0006]Poor preparation may therefore be detrimental to the quality of an
examination, in particular in the case of an examination by flexible
endoscopy, but also to the quality of a radiological examination where
stools may mimic the presence of polyps, or in case of an examination by
endoscopic capsule where the quality of the preparation has to be
excellent since the capsule navigates in the liquid contained in the
digestive tract which has to be perfectly clear (transparent) in order to
allow viewing of the mucosa.

[0007]In case of such an examination by endoscopic capsule, insufflation
or suction of debris and/or of turbid liquid cannot be authorized,
whereas the physician can actively intervene when a coloscope is used
(e.g. suction to clean, go back). The latter represents a reason why in
case of examination by endoscopic capsule, the quality of the preparation
has to be excellent. Upon use of endoscopic capsules the digestive tract
thus has to be prepared better than when using a coloscope to obtain the
same quality of images. This is confirmed in the abstract of `Capsule
Endoscopy versus Colonoscopy for the Detection of Polyps and Cancer`, N
Engl J Med 2009; 361:264-70.

[0008]All the procedures using colic compositions for flexible endoscopy
or radiological examination (coloscan) foresee a diet without residues
and administration of a laxative composition on the day before and/or the
day of the examination.

[0010]The quality of the examination might further be improved if this
clear liquid diet is also associated with the intake of laxative(s)
during the 36 hours preceding the conduction of the examination.

[0011]This type of prolonged administration of laxatives causes an
important discomfort for the patient which is increased by the intake of
a large amount of liquid together with a lack of supply of nutritive
elements. This may give rise to lipothymias, malaise, nauseas related to
fasting, altering the comfort of the patient and therefore his/her
availability upon conducting the examination but therefore also lowering
patient compliance with the diet prescribed by their physician in
preparation of the check-up. All of the above can give rise to a
suboptimal preparation and thus less reliable results, images for review
and diagnosis. Further, laxatives have a salty taste which makes their
ingurgitation unpleasant.

[0012]Polyethylene glycol (PEG) represents the basis of most colic
compositions, its macromolecules not being absorbed by the digestive
tract, allow an increase in the volume of intestinal liquids.
Accordingly, better hydrated stools transit faster in the colon and are
more easily evacuated. Other laxatives such as sodium phosphates may also
be used.

[0013]Presently there are several laxative or colic compositions on the
market: Colofort® (Ipsen), Colopeg® (Bayer), Endofalk®
(Codali), Fleet® Phosphosoda (Kela), Klean-Prep® (Norgine), etc.
Some of them attempt to solve the problem of unpleasant taste by adding
aromas.

[0014]In document US-A-20060073214, with the composition and/or the
preparation method, the ingestion of large amounts of liquid tolerated
with difficulty by the patient may be limited.

[0015]The ideal preparation method would reliably empty the colon of all
fecal material, have little effect on the gross or the microscopic
appearance of the mucosa, require a relatively short period for ingestion
and evaluation, cause little patient discomfort, and produce no
significant fluid-electrolyte shifts while maximizing the detection of
colonic disease. It becomes important to consider, in particular in the
field of capsule endoscopy, to be able to give nutrients while
preparations for long durations can be contemplated which remove any
opaque liquid residue at colon level.

[0031]The present invention also relates to a kit comprising:
[0032]either at least one sachet or flask containing the composition
according to the present invention, [0033]or at least one sachet or flask
containing a laxative, at least one sachet or flask containing one or
more mineral salts and at least one sachet or flask containing
carbohydrates,or at least one sachet or flask containing a laxative and
at least one sachet or flask containing one or more mineral salts and
carbohydrates.

[0034]The invention relates to an energetic or nutritive composition
comprising at least one compound having laxative properties and
nutrients.

[0035]The nutritive composition according to the present invention is
transparent (clear).

[0036]Preferentially, the compounds having laxative properties are
selected from the following classes of compounds: ballast laxatives,
lubricants, osmotic laxatives, contact laxatives, anthraquinone
derivatives, diphenylmethane derivatives and/or a mixture of these
compounds.

[0037]Preferentially, the compounds having laxative properties belong to
the class of osmotic laxatives.

[0038]Preferentially, the compound having laxative properties is
polyethylene glycol having a molecular weight greater than or equal to
3000 kDa.

[0039]Preferentially, the compound having laxative properties is
polyethylene glycol 3350.

[0040]The nutrients comprise carbohydrates which can be assimilated by the
human digestive system such as glucose, maltose, galactose, fructose,
saccharose, polysaccharides, etc.

[0043]Preferentially, the nutrients further comprise proteins which
respect the perfectly transparent (clear) character of the administered
liquid, i.e. the transparency to visible light.

[0044]Preferentially, said energetic or nutritive composition further
comprises at least one food additive.

[0045]Preferentially, one of the food additives is a sweetener.

[0046]Preferentially, one of the additives is a food additive having a
taste-correcting effect.

[0047]Preferentially, one of the food additives is a flavoring.

[0048]Said flavorings may be present in variable quantity and may be
adapted to everyone's taste.

[0049]Preferentially, said energetic or nutritive composition is packaged
in a unique sachet.

[0050]Alternatively, said energetic or nutritive composition is packaged
in at least two sachets.

[0051]Alternatively, said energetic or nutritive composition is
conditioned in at least one sachet and at least one container for liquids
(flask).

[0052]Alternatively, said energetic or nutritive composition is
conditioned in at least one container for liquids (flask).

[0053]Preferentially, this composition is a powder and/or a liquid
solution.

[0054]Preferentially, this composition is used for preparing a liquid
solution.

[0055]Preferentially, this liquid solution is obtained by mixing the
composition according to said invention and a solvent.

[0056]Preferentially, said solvent is water.

[0057]Preferentially, administration of said solution is performed orally.

[0058]Alternatively, this composition may be found as gelatin capsules or
tablets with enteric coating.

[0059]Alternatively, this composition may combine the aforementioned
administration forms.

[0060]The composition according to the present invention has an energy
value greater than or equal to 250 kcal.

[0061]Preferentially, said composition has an energy value greater than or
equal to 500 kcal.

[0062]Preferentially, said composition has an energy value greater than or
equal to 1000 kcal.

[0063]The present invention also relates to a kit assembly comprising:
[0064]either at least one sachet or one flask containing the energetic
nutritive composition, [0065]or at least one sachet or flask containing a
laxative, at least one sachet or flask containing one or more mineral
salts and at least one sachet or flask containing carbohydrates, forming
a composition according to the present invention. [0066]or at least one
sachet or flask containing a laxative and at least one sachet or flask
containing one or more mineral salts and carbohydrates, forming a
composition according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Composition 1:

[0067]This composition, made for a person of less than 80 kg, exists as a
powder to be diluted in water up to 1.5 liters.

[0073]This composition is a combination of electrolyte-PEG solution and
Nutrical® as nutritive solution. The (electrolyte-)PEG solution can
be any or a combination of the above described compositions 1, 2 and/or 3
made soluble in the above described clear liquid from the state of the
art. Nutrical® (Nutricia Advanced Medical Nutrition, Belgium) is a
carbohydrate beverage rich in energy with low water (moisture) and
mineral content. The use of this carbohydrate beverage is recommended for
people with insufficient energy intake or with an elevated need for
energy. The carbohydrate beverage as described above is being sold in
carton-based packages of 200 ml. Ingredients of this carbohydrate
beverage are: demineralized water, glucose syrup, maltose, dextrin,
acidity regulator (citric acid).

The Carbohydrate Beverage as Described Above's Average Analysis Per 100
ml:

[0076]In order to prepare the digestive tract to an endoscopic capsule
examination where the quality of the preparation has to be good to
excellent (grade 1 or 2 according to Eliakim et al.), the patient has to
follow the following administration: [0077]In the evening two days
before the examination, a sachet of composition 1 is made soluble in 1.5
liters of water and is administered to the patient. [0078]The day before
the examination, three sachets of composition 1 are made soluble in 3
times 1.5 liters of water and are administered to the patient during the
whole day. [0079]In the morning of the examination, a sachet of
composition 1 is made soluble in 1.5 liters and is administered to the
patient.

[0080]This allows the patient to feed exclusively on this composition
starting from two days before the examination. He/she should therefore
not take in additional liquid.

Example 1 Bis

[0081]In order to prepare the digestive tract to an endoscopic capsule
examination where the quality of the preparation has to be good to
excellent (grade 1 or 2 according to Eliakim et al.), the patient has to
follow the following administration: [0082]In the morning and at noon
two days before the examination, a contact laxative (e.g.: Senna
Alexandrina syrup) is administered to the patient. [0083]In the evening
two days before the examination, a sachet of composition 1 is made
soluble in 1.5 liters of water and is administered to the patient.
[0084]The day before the examination, three sachets of composition 1 are
made soluble in 3 times 1.5 liters of water and are administered to the
patient during the whole day. [0085]In the morning of the examination, a
sachet of composition 1 is made soluble in 1.5 liters and is administered
to the patient.

[0086]This allows the patient to feed exclusively on this composition
starting from two days before the examination. He/she should therefore
not take in additional liquid.

Example 2

[0087]In order to prepare the digestive tract for a radiological
examination (ColoScan) where the quality of the preparation has to be
excellent or good according to Vanner et al., the patient follows the
following procedure: [0088]One day before the examination, two sachets
of the composition 1 are made soluble in two times 1.5 liters of water
and are administered to the patient. [0089]In the morning of the
examination, a sachet of composition 1 is made soluble in 1.5 liters and
is administered to the patient.

[0090]This allows the patient to feed exclusively on this composition
starting from the day before the examination. He/she should therefore not
take in additional liquid.

Example 3

[0091]In order to prepare the digestive tract for diagnostic examination
with a colonoscope where the quality of the preparation has to be
satisfactory, good or excellent according to Vanner et al., the patient
follows the following procedure: [0092]One day before examination, two
amounts of the composition 2 are made soluble in two times 1.5 liters of
water and are administered to the patient. [0093]In the morning of the
examination, an amount of composition 2 is made soluble in 1.5 liters and
is administered to the patient.

[0094]This allows the patient to feed exclusively on this composition
starting from the day before the examination. He/she should therefore not
take in additional liquid

Example 4

[0095]In order to prepare the digestive tract for a therapeutic
intervention where the quality of the preparation has to be satisfactory,
good or excellent according to Vanner, the patient follows the following
procedure: [0096]The day before the examination, two amounts of
composition 3 are made soluble in two times 1.5 liters of water and are
administered to the patient. [0097]In the morning of the examination, an
amount of composition 3 is made soluble in 1.5 liters and is administered
to the patient.

[0098]This allows the patient to feed exclusively on this composition
starting from the day before the examination. He/she should therefore not
take in additional liquid.

Example 5

[0099]In order to prepare the digestive tract for PillCam®0 Colon 2
(Given Imaging Ltd., Israel) where the quality of the (oral bowel)
preparation has to be acceptable, preferably good or more preferably
excellent according to Vanner, the patient follows the following
procedure: [0100]Two days before the examination subject will have:
[0101]base line serum electrolyte or ions and blood sugar or glucose
level or glyc(a)emic index determined via collection of blood and
[0102]one liter of PEG solution in the evening, water (or any other of
the above described clear liquids from the state of the art) at will.
[0103]One day before the examination, composition 4 is administered to
the patient according to the following schedule: [0104]One liter PEG and
200 ml of the carbohydrate beverage of composition 4 in the morning,
[0105]400 ml of the carbohydrate beverage of composition 4 in the
afternoon and [0106]one liter PEG and 200 ml of the carbohydrate beverage
of composition 4 in the evening. [0107]On this day there is a total
intake of about 2000 kcal: 2(2×247 kcal)+(4×247 kcal)=1976
kcal. One meal equals about 700 kcal. [0108]Nil by mouth (to fast a
patient) except water (or any other of the above described clear liquids
from the state of the art) at will. [0109]Day of the examination subject
will have: [0110]base line serum electrolyte or ions and blood sugar or
glucose level or glyc(a)emic index determined via collection of blood and
[0111]one liter of PEG solution after ingestion of the proprietary
endoscopic capsule of the 1st paragraph of example 5.

[0112]The above described (electrolyte-)PEG (solution) can be any or a
combination of the above described compositions 1, 2 and/or 3 made
soluble in the above described clear liquid from the state of the art.

[0113]Healthy volunteers are subjected to the procedure of example 5 after
which physicians review the generated RAPID video. The technology behind
the endoscopic capsule is that it contains an imaging device and
light-source and it transmits images to the sensor array attached to the
patient's abdomen and to the data recorder attached to a belt around the
patient's waist. Images for review and diagnosis are downloaded by the
physician to the Given workstation, on which the proprietary RAPID
software is installed. Grading is done using a scale for each segmental
section of the colon and overall for the entire video, an excellent grade
is given when there is no more than small bits of adherent feces, a poor
grade when there is a large amount of fecal residue. The objectives of
this clinical trial or study are a.o.: test the hypothesis that
carbohydrate oral rehydration in combination with PEG would increase the
patient tolerance to the bowel preparation, evaluate efficiency in colon
cleansing (or the colon cleansing level) of combination of
electrolyte-PEG solution and the carbohydrate beverage of composition 4
for proprietary endoscopic capsule of the 1st paragraph of example
5, to evaluate patient adherence to the combined regimen, to evaluate
patient tolerance to the combined regimen, to evaluate the effect of the
regimen on capsule transient time, . . .